title: Validation of acute liver injury cases in a population-based cohort study of oral antimicrobial users.
abstract: We conducted a cohort study of acute, noninfectious liver injury among oral antimicrobial users. Potential cases were identified in the HealthCore Integrated Research Database (HIRD(SM)) population between July 1, 2001, and March 31, 2009, using ICD-9-CM codes primarily for acute and subacute necrosis of the liver, hepatic coma, and unspecified hepatitis. Liver test results were used to confirm case status according to published criteria. Two physician reviewers experienced in studying acute liver injury (blinded to study drug exposures) evaluated data abstracted from hospital and emergency department records to validate potential cases. Of 715 potential cases having claims associated with any of the primary screening codes, 312 (44%) were valid cases, 108 (15%) were not cases, and 295 (41%) were of uncertain status (records inadequate for validation). Among potential cases with adequate medical records, the PPV for presence of any of the primary codes was 74% (95% CI, 70%-78%). The highest PPV for a single code was for acute and subacute necrosis of the liver (84%; 95% CI, 77%-90%). Evaluation of cases of noninfectious liver injury using hospital and emergency department medical records continues to represent the preferred approach in studies using insurance claims data.
authors.forename: Christine L
authors.initials: CL
authors.lastname: Bui
authors.forename: James A
authors.initials: JA
authors.lastname: Kaye
authors.forename: Jordi
authors.initials: J
authors.lastname: Castellsague
authors.forename: Brian
authors.initials: B
authors.lastname: Calingaert
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: McQuay
authors.forename: Nuria
authors.initials: N
authors.lastname: Riera-Guardia
authors.forename: Catherine W
authors.initials: CW
authors.lastname: Saltus
authors.forename: Scott C
authors.initials: SC
authors.lastname: Quinlan
authors.forename: Crystal N
authors.initials: CN
authors.lastname: Holick
authors.forename: Peter M
authors.initials: PM
authors.lastname: Wahl
authors.forename: Kiliana
authors.initials: K
authors.lastname: Suzart
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Rothman
authors.forename: Mari-Ann
authors.initials: MA
authors.lastname: Wallander
authors.affiliation: RTI Health Solutions, 1440 Main Street, Suite 310, Waltham, MA 02451-1623, USA. jkaye@rti.org.
authors.forename: Susana
authors.initials: S
authors.lastname: Perez-Gutthann
mesh_terms: D000208:Acute Disease; D000890:Anti-Infective Agents / Q000009:adverse effects* / Q000627:therapeutic use; D016022:Case-Control Studies; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis*; D015331:Cohort Studies; D003128:Coma / Q000209:etiology; D005260:Female; D006801:Humans; D038801:International Classification of Diseases; D008297:Male; D008875:Middle Aged; D011153:Population; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012189:Retrospective Studies
chemical_list: D000890:Anti-Infective Agents